EUCTR2019-004823-20-FR进行中（未招募）1 期
An Open-Label Study to Evaluate the Long-Term Safety and Efficacy ofLanadelumab for Prevention Against Acute Attacks of Non-histaminergicAngioedema with Normal C1-Inhibitor (C1-INH)
Takeda Development Center Americas (TDCA)0 个研究点目标入组 75 人开始时间: 2021年12月21日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 75
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1. Males and females, 12 years of age and older diagnosed with non-histaminergic normal C1-INH angioedema at the time of enrollment into the antecedent Study SHP643-303.
- •2. Subjects must have completed the treatment period (through Day 182) of Study SHP643-303 without reporting a clinically significant treatment-emergent adverse event (TEAE) that would preclude subsequent exposure to lanadelumab.
- •3. Agree to adhere to the protocol-defined schedule of treatments, assessments, and procedures.
- •4. Males, or non-pregnant, non-lactating females who are of child-bearing potential and who agree to be abstinent or agree to comply with the applicable contraceptive requirements of this protocol for the duration of the study;
- •or females of non-childbearing potential, defined as surgically sterile (status post hysterectomy, bilateral oophorectomy, or bilateral tubal ligation) or post-menopausal for at least 12 months.
- •5. The subject (or the subject’s parent/legal guardian, if applicable) has provided written informed consent approved by the institutional review board/research ethics board/ethics committee (IRB/REB/EC) at any time prior to study start. If the subject is a minor (ie, <18 years of age), have a parent/legal guardian who is informed of the nature of the study provide written informed consent (ie, permission) for the minor to participate in the study before any study-specific procedures are performed. Assent will be obtained from minor subjects.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 2
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 70
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 3
排除标准
- •1. Discontinued from Study SHP643-303 after enrollment but before Visit 26 for any reason.
- •2. Presence of important safety concerns identified in Study SHP643-303 that would preclude participation in this study.
- •3. Dosing with an investigational product (IP, not including IP defined in antecedent Study SHP643-303) or exposure to an investigational device within 4 weeks prior to Day 0.
- •4. Subject has a known hypersensitivity to the investigational product or its components.
- •5. Have any condition (surgical or medical) that, in the opinion of the investigator or sponsor, may compromise their safety or compliance, preclude the successful conduct of the study, or interfere with interpretation of the results (eg, significant pre-existing illness or other major comorbidities that the investigator considers may confound the interpretation of study results).
研究者
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